About this role
Regulatory Affairs Expert (Medical Devices)
Your responsibilities:
• Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling • Ensure compliance with regulatory standards and testing requirements throughout product design and development • Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities • Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions • Coordinate regulatory product strategies • Lead regulatory aspects of product and process changes, including regulatory documentation.
Your profile:
• Master’s degree in Technical, Engineering, or Scientific fields • Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products • Knowledge of development and manufacturing processes • Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, IEC 60601 series) • Understanding of medical device regulations (e.g., FDA CFR, NMPA, MDR 2017/745) • Strong communication and interpersonal skills • Fluent in English, both written and spoken
Our offer for you:
There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
• The option to work on a hybrid basis • Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world • Individual opportunities for self-determined career planning and professional development • A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one • A large number of committed people with a wide range of skills, talents and experience • The benefits of a successful global corporation with the collegial culture of a medium-sized company